The hottest Medical Devices Substack posts right now

The Watchman device for preventing stroke in atrial fibrillation might not be as effective as promised.
Studies show a significant incidence of residual leaks after percutaneous left atrial appendage occlusion.
Patients should be aware of the downsides and lack of proven benefits before opting for LAAO over other stroke prevention methods.

The Aktiia Bracelet offers a cuffless way for 24/7 blood pressure monitoring with accuracy validated through studies.
Validation studies have shown that the Aktiia Bracelet performs well and satisfies established criteria for accuracy.
Continuous and unobtrusive monitoring provided by the Aktiia Bracelet can give a more accurate representation of blood pressure throughout the day and night, potentially improving cardiovascular outcomes.

New FDA rules require medical device makers to meet specific cybersecurity criteria for approval.
Manufacturers must offer updates and patches for cybersecurity and develop a plan for addressing postmarket vulnerabilities.
Rules focus on devices connected to the internet, like insulin pumps and pacemakers, not legacy technology.

Cochlear implant users, especially low-income earners, face challenges when their devices become obsolete or in need of repair, potentially leading to loss of hearing if they can't afford upgrades.
Repairing electronics could save Americans $50 billion annually; household could save approximately $382 per year by repairing electronics instead of replacing them.
Tensions between corporate profits and the care of individuals emerge in the realm of medical devices, showing the importance of supporting repair initiatives and community aid over consumption.

Noninvasive brain activity imaging allows for measuring and mapping brain activity without surgery or bulky machines.
Different imaging modalities like fNIRS, functional ultrasound, and portable MEG offer varying levels of convenience, spatial resolution, and depth of brain activity detection.
Innovations like functional ultrasound and OPM-MEG show promise in providing noninvasive and portable options for measuring brain activity.

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The founders of IVAC, Steve Sato and Wally Knute, were brilliant innovators in the medical device industry.
Sato and Knute invented a hospital thermometer with disposal tips and a pump for regulating IVs, revolutionizing medical procedures.
IVAC, the company they built, became a significant player in the medical device industry, yet their legacy has been largely forgotten.

FDA approval process for medical devices is different from prescription drugs
Understanding FDA's medical device classification is important for stock market understanding
Discussion on hundreds of public companies commercializing their own medical devices

Skilled technicians struggle with repairs due to lack of documentation, tools, and parts, causing delays for device users.
Independent technicians lack legal leverage to access tools and resources necessary to repair medical devices like wheelchairs and insulin pumps.
The FDA and FTC have supported right-to-repair policies for medical devices, emphasizing the importance of technicians in maintaining the healthcare system.

FDA authorized the first over-the-counter continuous glucose monitor (CGM), Dexcom Stelo Glucose Biosensor System, for individuals 18 and older not using insulin.
The CGM system aims to help users understand the effects of diet and exercise on blood sugar levels, providing glucose readings every 15 minutes with sensors lasting up to 15 days.
The FDA clearance for this device emphasizes increased health equity by making health monitoring more accessible, although some side effects like skin irritation and pain have been reported.